• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Maquet

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 Class 2 Recall
see related information
Date Posted June 21, 2013
Recall Status1 Terminated on September 18, 2014
Recall Number Z-1572-2013
Recall Event ID 65417
Product Classification Cannula, Injection - Product Code FGY
Product MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
Code Information Catalogue Number:Part Number: Lot Number are as follows: (1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566
Recalling Firm/
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Karen LeFevere
Manufacturer Reason
for Recall
The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Reprocessing Controls
Action Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification. If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
Quantity in Commerce 100 units (60 Domestic; 40 International)
Distribution Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.